Radius Health, Inc.RDUS announced positive data from the phase III ACTIVE study ( A baloparatide C omparator T rial I n V ertebral E ndpoints) on abaloparatide for the treatment of postmenopausal women suffering from osteoporosis.
Data from the study revealed that abaloparatide-SC (80 mcg), when dosed daily for 18 months, led to a significant reduction in the incidence of new vertebral and non-vertebral fractures in postmenopausal women with osteoporosis, compared to placebo. Results were published in the Journal of the American Medical Association (JAMA).
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We remind investors that abaloparatide is currently under review in both the U.S. and the EU for the treatment of women with postmenopausal osteoporosis.
An opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing application is expected in late 2016 or in 2017. Meanwhile, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Mar 30, 2017.
In addition, the company is developing abaloparatide-transdermal (abaloparatide-TD) for potential use as a treatment for osteoporosis.
As per information provided by the company in its press release, approximately two million osteoporotic fractures take place annually in the U.S. This number is likely to grow to three million by 2025.
According to the National Osteoporosis Foundation (NOF), an estimated 10 million individuals in the U.S., comprising eight million women and two million men, are affected by osteoporosis, while an estimated 44 million individuals have demonstrated low bone mass, placing them at high risk for osteoporosis.
Drugs currently approved to treat osteoporosis include Actonel, Fosamax and Forteo among others.
Radius Health currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Geron Corporation GERN , Anika Therapeutics Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP . Each of these stock sports a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
